コンピュータ診断支援装置におけるソフトウェア設計・開発管理
Contents
1. 16 1 2 1 9 16 GHTF 0331012 22. 7 vi vil CADe CADx i 2 ii iii
3. CAD 5 iv i li ii CAD
4. 2012 2 5 3 1 2 3 1 2 4 1 2 5 1 2 6 wm Appendix IEC62304 IEC62304 cn Oa ee 2012 1 CADe Computer Aided Detection
5. IEC62304 IEC62304 XXX YYYYYY 1 B 4 IEC62304 4 1 AAA QMS amp a QMS 4 2 a BBB RM ah2z 22 am comozoow 5 5 1 planning 511 pl ppp fa ou ee ECE 5 1 5 ae DDD xx Ce he Ber 5 2 5 21 EEE A C 11 4
6. i Bl Ww i SOUP ii SOUP i li
7. CAD 5 1 4 CAD TEC62304 2 4 6 IEC62304 Medical device software Software life cycle processes JIS Q 13485
8. IEC62304 JIS Q 13485 i CAD CADe CADx ii CAD FAD Focal Asymmetric Density CADe CADx ii TEC62304 4 3 a A B C
9. PC HY CAD QMS ISO13485 JISTO601 1 PC QMS SO9001 JISC6930 1 12 m ou HE iF mente lt Ff 23
10. 2 CAD CADe CADx 3 CAD 2 1 CADe CADx IEBC62304 Medical device software Software life cycle
11. 9 1 gt 1EC62304 12 IEC62304
12. CAD WG
13. CADx Computer Aided Diagnosis J CAD IEC IEC62304 Medical device software Software life cycle processes CAD CAD 2
14. CPU OS iv v
15. Bl FAD CADe CADx iii CADe CADx iV CADe CADx V 4 jEC62304 Software Of Unknown Provenance off the shelf
16. CADe 2 CADx i SOUP SOUP SOUP SOUP ii
17. WG
18. 10 2 IEC62304 CAD CAD 9 12 IEC62304 IEC62304 IEC62304 IEC62304 3 IEC62304 IEC62304
19. JIS T 14971 Appendix 1 122 IEC62304 CAD
20. processes KU JIS Q 13485 2 CAD IEC62304 1 CAD CAD A BRIEC B IEC62304 2
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